Deep brain stimulation (DBS) and other related procedures involving implantation of leads and catheters are increasingly used to treat Parkinson's disease, dystonia, essential tremor, seizure disorders, obesity, depression, restoration of motor control, and other debilitating diseases. During these procedures, a catheter, lead, or other medical device is strategically placed at a target site in the brain. The body of the device then exits through a burr hole cut in the skull. The device must be secured as it exits the skull so as to prevent movement of the device from the precise target site in the brain, and the burr hole must be filled.
Current burr hole plugs placed under the skin of a patient's head are unduly large and unsightly. Further, many current burr hole plugs do not adequately hold the exiting device in place; some force the device to bend at a right angle at the exit without any protection which makes the device vulnerable to fracture or short circuit. During placement of current burr hole plugs, the exiting device often moves from its precise target site in the brain. After placement of current burr hole plugs, the device may migrate over time and will require additional surgical procedures to correct the problem.
Due to a lack of adequate burr hole plugs, many physicians attempt to compensate by securing the device to the skull with sutures and clamping screws, and then filling the burr hole with cyanoacrylate or bone cement. Securing the device with sutures and clamping screws subjects the patient to unnecessary human error. Further, suturing and clamping are cumbersome and time consuming steps. Filling the burr hole with cyanoacrylate or bone cement is messy and permanently locks the device into place, preventing easy access for future necessary procedures.
There is, therefore, a need to provide a relatively small burr hole plug that, without disturbing the position of the device at the target site in the brain, adequately and permanently secures a medical device such as a catheter or lead exiting a burr hole at a gradual angle, but remains accessible for future procedure. Further, there is a need to provide a method of implanting a burr hole plug that mitigates human error and permits safe and efficient implantation.